BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2230483 · Received August 12, 2011

    Report

    Report Number
    1644487-2011-01854
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 15, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT INFORMATION WAS RECEIVED FROM THE IMPLANTING HOSPITAL AND HAS BEEN INCLUDED IN THIS MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BEEN HAVING HIGH BLOOD PRESSURE FOR THE PAST 4 WEEKS. HE BLOOD PRESSURE WAS 190/161. PER REPORTER, THE VNS WAS TURNED OFF AND THE BLOOD PRESSURE WENT BACK TO NORMAL. THE PHYSICIAN DECIDED TO TURN THE VNS BACK ON AS PT BEGAN HAVING MORE SEIZURES, AND THE BLOOD PRESSURE INCREASED AGAIN. HOWEVER, THE PT HAS NOW BEEN SEIZURE-FREE WITH VNS ON. PT WAS PUT ON THE BLOOD PRESSURE MEDICATION WHICH DECREASED HER BLOOD PRESSURE TOO MUCH. FOLLOW-UP WITH THE PHYSICIAN REVEALS THAT THE PT'S PHYSICIANS DON'T REALLY THINK THE VNS IS THE CAUSE OF THE HIGH BLOOD PRESSURE, BUT THE PT'S FATHER FEELS IT IS. THE PT WAS PUT ON BLOOD PRESSURE MEDICATION WHICH THAT PT HAS BEEN TAKING FOR A WEEK AND THE BLOOD PRESSURE IS NOW DOWN TO 126/88. THE VNS IS ON AT LOW SETTINGS CURRENTLY AND THE PT IS SEIZURE-FREE. IT WAS NOTED THAT VIMPAT MAY HAVE BEEN THE CAUSE OF THE INCREASED BLOOD PRESSURE, THOUGH THIS CANNOT BE CONFIRMED. SYSTEM DIAGNOSTICS INDICATE PROPER VNS DEVICE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 201534

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR